TABLE 5.
Summary of primary and key secondary efficacy endpoints by %fT>MIC and MIC cutoff values for ceftolozane/tazobactama
| MIC cutoff, μg/mL | Exposure | n | %ƒT>MICb | 28-day all-cause mortality, % | Clinical cure at TOC, % |
|---|---|---|---|---|---|
| ≤1 | %fT>MIC of 99.0% | 141 | NA | 13.5 | 71.6 |
| %fT>MIC <99.0% | 1 | 86.1% | 0.0 | 100.0 | |
| ≤2 | %fT>MIC of 99.0% | 160 | NA | 13.8 | 70.0 |
| %fT>MIC <99.0% | 1 | 86.1% | 0.0 | 100.0 | |
| ≤4 | %fT>MIC of 99.0% | 173 | NA | 13.3 | 70.0 |
| %fT>MIC <99.0% | 4 | 73.7%, 84.0%, 86.1%, 89.2% | 0.0 | 100.0 | |
| ≤8 | %fT>MIC of 99.0% | 182 | NA | 13.7 | 67.6 |
| %fT>MIC <99.0% | 6 | 63.3%, 68.5%, 73.7%, 84.0%, 86.1%, 89.2% | 0.0 | 83.3 |
a
%fT>MIC, percentage of time the concentration of free ceftolozane in plasma exceeded the MIC; NA, not applicable; TOC, test of cure.
b
Individual values for each pathogen with <99% fT>MIC are listed individually.